Find Related Trials for The Following Conditions

General Information

Remodulin (treprostinil sodium) injection is a continuous
subcutaneous infusion for the treatment of pulmonary arterial
hypertension (PAH) in patients with NYHA Class II-IV symptoms.
Remodulin is intended to diminish the symptoms, such as shortness
of breath, associated with physical activity in PAH patients.

Remodulin is supplied in concentrations of 1.0 mg/mL, 2.5 mg/mL,
5.0 mg/mL and 10.0 mg/mL. The standard infusion rate is 1.25
ng/kg/min, but can be reduced in the event that the original dose
cannot be tolerated.

Pulmonary arterial hypertension (PAH) is a disease in which
blood pressure is abnormally high in the arteries between the heart
and lungs. PAH is characterized by symptoms of shortness of breath
during physical exertion. The condition can ultimately lead to
heart failure.

Clinical Results

Two 12-week, multicenter, randomized, double-blind studies were
conducted to compare Remodulin to placebo. A total of 470 subjects
with NYHA Class II-IV pulmonary arterial hypertension (PAH) we
enrolled in the studies. The baseline measures were 6-minute
walking distance and level of shortness of breath during this
physical test (Borg dyspnea score). The primary endpoint was change
in 6-minute walking distance over the 12-week treatment period.
There was a noteworthy change in 6-minute walking distance for
those subjects treated with Remodulin, although the effects did not
achieve conventional levels of statistical significance. There was
a statistically significant change in subjects' Borg dyspnea
scores with the Remodulin treatment. There were significant
differences between Remodulin- and placebo-treated subjects in
eight out of ten hemodynamic parameters that were evaluated,
including cardiac index; mean pulmonary arterial pressure;
pulmonary vascular resistance indexed; mean right atrial pressure;
systemic vascular resistance indexed; mixed venous oxygen
saturation. The two hemodynamic parameters that did not achieve
statistical significance were mean systemic arterial pressure and
heart rate.

At the time of FDA approval, clinical studies of Remodulin were
still ongoing for the PAH indication to explore further effects and
potential benefits of the drug. In addition, a post-marketing,
phase IV clinical trial is expected to commence.

Side Effects

In clinical trials, infusion site pain and infusion site
reaction were the most frequently reported adverse events. Both of
these effects were experienced by over 80% subjects receiving
Remodulin therapy.

The following adverse events were also reported in clinical
trials:

Headache

Diarrhea

Nausea

Rash

Jaw pain

Vasodilatation

Dizziness

Edema

Pruritus (itching)

Hypotension

Mechanism of Action

The major pharmacological actions of treprostinil are direct
vasodilation of pulmonary and systemic arterial vascular beds and
inhibition of platelet aggregation. (From prescribing
information)

Additional Information

For additional information about Remodulin, please visit the
United Therapeutics web site at
www.unither.com.